SWEET TIP RX/ FLEXTEND LEAD FAMILY
FDA premarket approval P960006/S039 · decided 2013-08-07
Approval details
- PMA number
- P960006
- Supplement
- S039
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SWEET TIP RX/ FLEXTEND LEAD FAMILY
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Boston Scientific
- Date received
- 2013-05-16
- Decision date
- 2013-08-07
- Days to decision
- 83 days
- Decision code
- APPR
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR LEAD STABILIZER KIT 6503 AND LEAD CAP KIT 6504, WHICH ARE ACCESSORY KITS INTENDED TO BE USED WITH THE BOSTON SCIENTIFIC CORPORATION (BSC) LEAD PRODUCTS APPROVED IN THE DEVICES.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.